BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7196862 · Received January 16, 2018

    Report

    Report Number
    8031673-2017-00290
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 18, 2017
    Report Date
    October 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 19-DEC-2017 A FIELD SERVICE ENGINEER (FSE) FOLLOWED-UP OVER-THE-PHONE WITH THE CUSTOMER. THE FSE WALKED THE CUSTOMER THROUGH TROUBLESHOOTING THE AIA-2000 INSTRUMENT AND FOUND THAT THE TUBING ON THE WASH SOLUTION BOTTLE WAS KINKED, CAUSING THE WASH SOLUTION NOT TO FLOW PROPERLY. THE CUSTOMER REPLACED THE KINKED TUBING AND THE FILTER AS WELL. THE CUSTOMER PRIMED THE AIA-2000 INSTRUMENT WITHOUT ANY FURTHER ISSUES. THE AIA-2000 INSTRUMENT WAS OPERATING WITHIN SPECIFICATIONS. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE AIA-2000, SERIAL (B)(4), FROM 18-NOV-2016 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER SECTION 6. SYSTEM OPERATION STATES THE FOLLOWING: 6.2.2 MAINTENANCE ROUTINE (1) PRIMING THE SUBSTRATE LINE PRIME THE SUBSTRATE LINE WITH THE SUBSTRATE. (2) FLUSH THE WASH SOLUTION FLUSH OUT ANY WASH SOLUTION REMAINING IN THE WASH LINES. THE FOLLOWING ERROR MESSAGES APPEAR IF THE WASH SOLUTION IS NOT PROPERLY FLUSHED. "2239: B/F PROBE 1 FLUSH FAILURE" APPEARS WHEN B/F PROBE 1 FLUSH FAILS. "2240: B/F PROBE 2 FLUSH FAILURE" APPEARS WHEN B/F PROBE 2 FLUSH FAILS. "2241: B/F PROBE 3 FLUSH FAILURE" APPEARS WHEN B/F PROBE 3 FLUSH FAILS. "2242: B/F PROBE 4 FLUSH FAILURE" APPEARS WHEN B/F PROBE 4 FLUSH FAILS. THESE MESSAGES INDICATE THAT AIR WAS NOT COMPLETELY FLUSHED FROM THE WASH SOLUTION LINES. IF ERRORS OCCUR, PRESS THE B/F PROBE KEY ON THE AIA-2000 SHEET KEY, OPEN THE COVER AND CHECK B/F UNIT FOR POSSIBLE CAUSES OF THE MALFUNCTION. AFTER THIS, CLICK PRIME WASH SOLUTION BUTTON ON THE OPERATION PANEL (TOOLBAR) TO REPEAT THE FLUSH PROCEDURE UNTIL THE LINES ARE FULL AND THE ERRORS STOP. CONTACT A TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES IF ERROR MESSAGES STILL APPEAR AFTER FLUSHING 5 TIMES OR MORE. SECTION A4. APPENDIX 4: ERROR MESSAGES STATE THE FOLLOWING: 2239 B/F PROBE 1 PURGE FAILURE CAUSE: THE OVERFLOW SENSOR FAILED TO DETECT LIQUID EVEN AFTER THE WASHER WAS PURGED. SOLUTION: AIR MAY BE TRAPPED IN THE WASHER TUBING. PURGE ANY REMAINING AIR BY PERFORMING THE PRIMING OPERATION AND CHECK FOR THE PRESENCE OF AIR IN THE WASHER TUBING. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. 2240 B/F PROBE 2 PURGE FAILURE CAUSE: THE OVERFLOW SENSOR FAILED TO DETECT LIQUID EVEN AFTER THE WASHER WAS PURGED. SOLUTION: AIR MAY BE TRAPPED IN THE WASHER TUBING. PURGE ANY REMAINING AIR BY PERFORMING THE PRIMING OPERATION AND CHECK FOR THE PRESENCE OF AIR IN THE WASHER TUBING. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. 2241 B/F PROBE 3 PURGE FAILURE CAUSE: THE OVERFLOW SENSOR FAILED TO DETECT LIQUID EVEN AFTER THE WASHER WAS PURGED. SOLUTION: AIR MAY BE TRAPPED IN THE WASHER TUBING. PURGE ANY REMAINING AIR BY PERFORMING THE PRIMING OPERATION AND CHECK FOR THE PRESENCE OF AIR IN THE WASHER TUBING. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. 2242 B/F PROBE 4 PURGE FAILURE CAUSE: THE OVERFLOW SENSOR FAILED TO DETECT LIQUID EVEN AFTER THE WASHER WAS PURGED. SOLUTION: AIR MAY BE TRAPPED IN THE WASHER TUBING. PURGE ANY REMAINING AIR BY PERFORMING THE PRIMING OPERATION AND CHECK FOR THE PRESENCE OF AIR IN THE WASHER TUBING. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO A KINKED TUBING ON THE WASH SOLUTION BOTTLE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 2239 B/F PROBE 1 PURGE FAILURE, 2240 B/F PROBE 2 PURGE FAILURE, 2241 B/F PROBE 3 PURGE FAILURE, AND B/F 2242 PROBE 4 PURGE FAILURE ERROR MESSAGES WHILE RUNNING PATIENT SAMPLES ON THE AIA-2000 INSTRUMENT. THE CUSTOMER WAS DOWN AND UNABLE TO RUN THE AIA-2000 INSTRUMENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR FOLLICLE STIMULATING HORMONE (FSH), ESTRADIOL (E2), LUTEINIZING HORMONE (LH II), PROLACTIN (PRL), AND PROGESTERONE (PROG). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4), PER EXEMPTION NUMBER E2017013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38498 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1